My June 2025 article, “How to Avoid FDA Warning Letters,” points out that inadequate corrective and preventive action (CAPA) is a major reason

I had a great conversation with a friend of mine. He was bemoaning the fact that his company was almost completely dependent on one huge customer. He saw the inherent risks in that relationship but confessed that his organization had a bad habit it couldn’t kick.

We’d be willing to bet your key collaborators aren’t all in the same building. Your team members, contract partners, clients, and suppliers are likely scattered across the globe.

The use of artificial intelligence (AI) models, specifically generative AI, is growing. This has raised concerns about the effects on jobs in various professions. The quality profession is among them.

Ninety days to implementation vs. 12 to 18 months with traditional systems: That’s not just an incremental improvement—it’s a complete reimagining of what’s possible in life sciences quality management.

AI has amazing capabilities, and it’s one of the best technologies for the future. It’s helping to change the world and bringing productivity enhancements across industries with its exceptional use cases. Quality assurance isn’t left out, either.

Many organizations have decided to automate their quality management system (QMS) or upgrade their currently automated QMS.

The case for in-office work has never been stronger. This may seem surprising, given that many businesses have operated remotely or in hybrid models for more than five years.

When an issue arises, it’s important to take quick action. Whether that means launching a software patch, pulling a batch, or halting the use of a reagent, it’s critical to tackle the immediate problem.

My first day as a consultant coincided with the annual women’s summit, and so the other female new hires and I were invited to join the event.